Adjuvant combination formulations

Abstract

The use of 3-O-deacylated monophosphoryl lipid A or monophosphoryl lipid A and derivatives and analogs thereof, in combination with a cytokine or lymphokine such as granulocyte macrophage colony stimulating factor or interleukin-12 is useful as an adjuvant combination in an antigenic composition to enhance the immune response in a vertebrate host to a selected antigen.

1 . An antigenic composition consisting of an antigen and an effective adjuvanting amount of the combination of: (1) a stable oil-in-water emulsion of 3-0-deacylated monophosphoryl lipid A or monophosphoryl lipid A (MPL-SE) and (2) interleukin-12 (IL-12), together with a diluent or carrier, wherein the combination of adjuvants enhances the immune response in a vertebrate host to said antigen. 
     
     
         2 . The antigenic composition of  claim 1 , where the antigen is a polypeptide, peptide or fragment derived from a protein. 
     
     
         3 . (canceled) 
     
     
         4 . The antigenic composition of  claim 1 , where the antigen is derived from a pathogenic virus. 
     
     
         5 . A method for increasing the ability of an antigenic composition containing an antigen from a pathogenic virus to elicit an immune response in a vertebrate host against said pathogenic virus, which comprises administering to said host an antigenic composition of  claim 4 . 
     
     
         6 . A method for increasing the ability of an antigenic composition containing an antigen from a pathogenic virus to elicit cytotoxic T lymphocyte responses in a vertebrate host, which comprises administering to said host an antigenic composition of  claim 4 . 
     
     
         7 . The antigenic composition of  claim 4 , where the antigen is from human immunodeficiency virus (HIV). 
     
     
         8 . The antigenic composition of  claim 7 , where the HIV antigen is an HIV protein, polypeptide, peptide or fragment derived from said protein. 
     
     
         9 . The antigenic composition of  claim 8  where the antigen is the HIV peptide having the amino acid sequence: Lys Gln Ile Ile Asn Met Trp Gln Glu Val Gly Lys Ala Met Tyr Ala Cys Thr Arg Pro Asn Tyr Asn Lys Arg Lys Arg Ile His Ile Gly Pro Gly Arg Ala Phe Tyr Thr Thr Lys (SEQ ID NO:1), or Lys Gln Ile Ile Asn Met Trp Gln Glu Val Gly Lys Ala Met Tyr Ala Thr Arg Pro Asn Tyr Asn Lys Arg Lys Arg Ile His Ile Gly Pro Gly Arg Ala Phe Tyr Thr Thr Lys (SEQ ID NO:2). 
     
     
         10 . (canceled) 
     
     
         11 . A method for increasing the ability of an antigenic composition containing an HIV antigen to elicit an immune response to said antigen in a vertebrate host, which comprises administering to said host an antigenic composition of  claim 7 . 
     
     
         12 . The method of  claim 11 , where the HIV antigen is the HIV peptide having the amino acid sequence: Lys Gln Ile Ile Asn Met Trp Gln Glu Val Gly Lys Ala Met Tyr Ala Thr Arg Pro Asn Tyr Asn Lys Arg Lys Arg Ile His Ile Gly Pro Gly Arg Ala Phe Tyr Thr Thr Lys (SEQ ID NO:2). 
     
     
         13 . A method for increasing the ability of an antigenic composition containing an HIV antigen to elicit cytotoxic T lymphocyte responses in a vertebrate host, which comprises administering to said host an antigenic composition of  claim 7 . 
     
     
         14 . The method of  claim 13 , where the HIV antigen is the HIV peptide having the amino acid sequence: Lys Gln Ile Ile Asn Met Trp Gln Glu Val Gly Lys Ala Met Tyr Ala Thr Arg Pro Asn Tyr Asn Lys Arg Lys Arg Ile His Ile Gly Pro Gly Arg Ala Phe Tyr Thr Thr Lys (SEQ ID NO:2).